Development of instrument to report and assess causality of adverse events related to herbal medicines

Abstract: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow...

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Autores principales:	Patrícia de Carvalho Mastroianni, Fabiana Rossi Varallo, Marília Amaral Costa, Luis Vitor da Silva Sacramento
Formato:	article
Lenguaje:	EN
Publicado:	Universidad de Antioquia
Materias:	Herbal medicine adverse drug reaction reporting systems pharmacovigilance risk assessment product Surveillance postmarketing Food processing and manufacture TP368-456 Pharmaceutical industry HD9665-9675
Acceso en línea:	https://doaj.org/article/6322aa85b4ae499faf76b14ed425a7b9
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spelling	oai:doaj.org-article:6322aa85b4ae499faf76b14ed425a7b92021-12-02T07:01:14ZDevelopment of instrument to report and assess causality of adverse events related to herbal medicines0121-400410.17533/udea.vitae.v24n1a02https://doaj.org/article/6322aa85b4ae499faf76b14ed425a7b9http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0121-40042017000100013&lng=en&tlng=enhttps://doaj.org/toc/0121-4004Abstract: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.Patrícia de Carvalho MastroianniFabiana Rossi VaralloMarília Amaral CostaLuis Vitor da Silva SacramentoUniversidad de AntioquiaarticleHerbal medicineadverse drug reaction reporting systemspharmacovigilancerisk assessmentproduct SurveillancepostmarketingFood processing and manufactureTP368-456Pharmaceutical industryHD9665-9675ENVitae, Vol 24, Iss 1, Pp 13-22
institution	DOAJ
collection	DOAJ
language	EN
topic	Herbal medicine adverse drug reaction reporting systems pharmacovigilance risk assessment product Surveillance postmarketing Food processing and manufacture TP368-456 Pharmaceutical industry HD9665-9675
spellingShingle	Herbal medicine adverse drug reaction reporting systems pharmacovigilance risk assessment product Surveillance postmarketing Food processing and manufacture TP368-456 Pharmaceutical industry HD9665-9675 Patrícia de Carvalho Mastroianni Fabiana Rossi Varallo Marília Amaral Costa Luis Vitor da Silva Sacramento Development of instrument to report and assess causality of adverse events related to herbal medicines
description	Abstract: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow detection and evaluation of the causal likelihood of AE related to herbal medicines. Methods: A quantitative methodological development research intervention was performed with primary care health professionals. Two cases were distributed in an interval of one week in order to allow for completion of the proposal form. The within-rater reliability was calculated and classified into satisfactory, regular, and unsatisfactory, according to essential, necessary, and recommended items reported. Results: Fifty-seven professionals were enrolled. A high degree of the within-rater reliability was observed for the most essential, necessary, and recommended fields. The instrument contributed to assessment of definite causal association, once the duration of reactions including evolution, withdrawal, and reposition items showed high reliability. Most fields poor and weak filled were related to quality defects, such as popular name and appearance. Conclusions: Data suggest the instrument is adequate to report AE arising from herbal medicines. Owing to information regarding to organoleptic characteristics, the instrument is different from drug instruments. Therefore, it is intended to improve AE reports related to herbal medicines and contribute for appropriate use.
format	article
author	Patrícia de Carvalho Mastroianni Fabiana Rossi Varallo Marília Amaral Costa Luis Vitor da Silva Sacramento
author_facet	Patrícia de Carvalho Mastroianni Fabiana Rossi Varallo Marília Amaral Costa Luis Vitor da Silva Sacramento
author_sort	Patrícia de Carvalho Mastroianni
title	Development of instrument to report and assess causality of adverse events related to herbal medicines
title_short	Development of instrument to report and assess causality of adverse events related to herbal medicines
title_full	Development of instrument to report and assess causality of adverse events related to herbal medicines
title_fullStr	Development of instrument to report and assess causality of adverse events related to herbal medicines
title_full_unstemmed	Development of instrument to report and assess causality of adverse events related to herbal medicines
title_sort	development of instrument to report and assess causality of adverse events related to herbal medicines
publisher	Universidad de Antioquia
url	https://doaj.org/article/6322aa85b4ae499faf76b14ed425a7b9
work_keys_str_mv	AT patriciadecarvalhomastroianni developmentofinstrumenttoreportandassesscausalityofadverseeventsrelatedtoherbalmedicines AT fabianarossivarallo developmentofinstrumenttoreportandassesscausalityofadverseeventsrelatedtoherbalmedicines AT mariliaamaralcosta developmentofinstrumenttoreportandassesscausalityofadverseeventsrelatedtoherbalmedicines AT luisvitordasilvasacramento developmentofinstrumenttoreportandassesscausalityofadverseeventsrelatedtoherbalmedicines
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Development of instrument to report and assess causality of adverse events related to herbal medicines

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